A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin

NCT07118215 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CN012-0013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.

Conditions

Healthy Volunteers

Keywords

Healthy volunteer; Pharmacokinetics; BMS-986510; KarXT; Cobenfy; Midazolam; Fexofenadine; Digoxin; Drug-drug interaction

Outcome Measures

Primary Outcomes (6)

• Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT

  Up to approximately day 24

• Part 1/1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT

  Up to approximately day 24

• Part 2: GMR of Cmax of fexofenadine with and without KarXT

  Up to approximately day 24

• Part 2: GMR of AUC of fexofenadine with and without KarXT

  Up to approximately day 24

• Part 3: GMR of Cmax of digoxin with and without KarXT

  Up to approximately day 24

• Part 3: GMR of AUC of digoxin with and without KarXT

  Up to approximately day 24

Secondary Outcomes (8)

• Number of participants with adverse events (AEs)

  Up to approximately day 47

• Number of participants with serious adverse events (SAEs)

  Up to approximately day 47

• Number of participants with physical examination abnormalities

  Up to approximately day 24

• Number of participants with vital sign abnormalities

  Up to approximately day 24

• Number of participants with 12-lead electrocardiogram abnormalities (ECGs)

  Up to approximately day 24

Study Arms (4)

Part 1

EXPERIMENTAL

Drug: KarXT; Drug: Midazolam

Part 2

EXPERIMENTAL

Drug: KarXT; Drug: Fexofenadine

Part 3

EXPERIMENTAL

Drug: KarXT; Drug: Digoxin

Part 1a

EXPERIMENTAL

Drug: KarXT; Drug: Midazolam

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510, Xanomeline, Trospium Chloride

Part 1; Part 1a; Part 2; Part 3

Midazolam DRUG

Specified dose on specified days

Part 1; Part 1a

Fexofenadine DRUG

Specified dose on specified days

Part 2

Digoxin DRUG

Specified dose on specified days

Part 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
• Participants must have BMI of 18.0 to 32.0 kg/m2.

You may not qualify if:

• Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
• Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results.
• Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.
• Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
• Participants must not have current or recent (within 3 months of first study intervention administration) GI disease that could possibly affect drug ADME (eg, bariatric procedure).
• Participants must not have any major surgery, including GI surgery (eg, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
• Participants must not have history of active GI obstructive disorder.
• Participants must not have history of bladder stones.
• Participants must not have history of recurrent urinary tract infections.

Sponsors & Collaborators

• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (1)

ICON - Lenexa

Lenexa, Kansas, 66219-9746, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

xanomeline; trospium chloride; Midazolam; fexofenadine; Digoxin

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: September 29, 2025
• Primary Completion: April 5, 2026
• Study Completion: April 5, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)